J. Phys. Ther. Sci. 28: 360–365, 2016
The Journal of Physical Therapy Science Original Article
Assessment of the effect of pelvic floor exercises on pelvic floor muscle strength using ultrasonography in patients with urinary incontinence: a prospective randomized controlled trial Ozge Celiker Tosun1), Ulas Solmaz2), Atalay Ekin2)*, Gokhan Tosun2), Cenk Gezer 2), Ahmet Mete Ergenoglu3), Ahmet Ozgur Yeniel3), Emre Mat2), Mehtap Malkoc4), Niyazi Askar3) 1) School
of Physiotherapy and Rehabilitation, Dokuz Eylul University, Turkey of Obstetrics and Gynecology, Tepecik Training and Research Hospital: Gaziler Street, No: 468, Izmir, Turkey 3) Department of Obstetrics and Gynecology, Ege Faculty, University of Medicine, Turkey 4) School of Physiotherapy and Rehabilitation, Dogu Akdeniz University, North Cyprus 2) Department
Abstract. [Purpose] The aim of this study was to evaluate whether the effect of pelvic floor exercises on pelvic floor muscle strength could be detected via ultrasonography in patients with urinary incontinence. [Subjects and Methods] Of 282 incontinent patients, 116 participated in the study and were randomly divided into a pelvic floor muscle training (n=65) group or control group (n=51). The pelvic floor muscle training group was given pelvic floor exercise training for 12 weeks. Both groups were evaluated at the beginning of the study and after 12 weeks. Abdominal ultrasonography measurements in transverse and longitudinal planes, the PERFECT scheme, perineometric evaluation, the stop test, the stress test, and the pad test were used to assess pelvic floor muscle strength in all cases. [Results] After training, the PERFECT, perineometry and transabdominal ultrasonography measurements were found to be significantly improved, and the stop test and pad test results were significantly decreased in the pelvic floor muscle training group, whereas no difference was observed in the control group. There was a positive correlation between the PERFECT force measurement scale and ultrasonography force measurement scale before and after the intervention in the control and pelvic floor muscle training groups (r=0.632 and r=0.642, respectively). [Conclusion] Ultrasonography can be used as a noninvasive method to identify the change in pelvic floor muscle strength with exercise training. Key words: Pelvic floor muscle, Transabdominal ultrasonography, Urinary incontinence (This article was submitted Aug. 25, 2015, and was accepted Oct. 30, 2015)
INTRODUCTION Urinary incontinence (UI) has been defined as the complaint of any involuntary loss of urine. The published prevalence rates of UI in adult women vary from 5 to 69%1). The physiopathology of UI is multifactorial, and it is known that weak pelvic floor muscles (PFMs) represent a problem encountered in patients with UI2). The PFMs play an important role in the maintenance of continence. Therefore, the purpose of PFM training is to increase strength and endurance as well as to provide neuromuscular facilitation3). PFM training is generally recommended as the first choice of treatment for stress and mixed UI in women4). *Corresponding author. Atalay Ekin (E-mail:
[email protected]) ©2016 The Society of Physical Therapy Science. Published by IPEC Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (by-nc-nd) License .
Several subjective and objective methods have been used to assess PFM function in women attending physical therapy and exercise programs. The most commonly used tool in physical therapy seems to be digital palpation (modified Oxford Grading Scale)5). The PERFECT scheme (Power, Endurance, Repetition, Fast contractions, Every Contraction Timed) was developed to assess the primary components of PFM contractility via digital palpation2). Real-time ultrasound imaging is a rapidly developing technique that is used by physical therapists to assess muscle structure, function, and activation patterns6–8). Unlike other methods that require intravaginal application, transabdominal ultrasonography (TAUS) has the advantages of noninvasiveness, comfort, and appropriateness in a specific population in which vaginal assessment may not be favorable (children, adolescents, victims of sexual abuse, men, and certain ethnic groups) with quick and easy applications9). TAUS has been found to be a valid and reliable method to measure the movement of the bladder base as an indicator of PFM activity during muscle contraction10). However, only patients with a score of 3 and above in muscle strength according to digital palpation were included in these studies10–13). In addition, to our knowledge, no study has investigated the correlation between TAUS measurement and the parameters of the PERFECT scheme. Therefore, our aim was to measure the PFM strength objectively by TAUS before and after PFM training in patients with all levels of PFM strength (0–5) and to compare the findings of TAUS with digital palpation.
SUBJECTS AND METHODS This was a prospective randomized controlled clinical trial with testing performed before and after training. Approval was obtained from the Dokuz Eylul University Human Ethics Committee (Number: A 38 GOA 385 1.12.11) prior to this study, and written informed consent was obtained from subjects. The patients of this study included 282 incontinent women selected from the individuals observed at a urogynecology unit. The exclusion criteria were pregnancy, pelvic organ prolapses, low back pain, spinal or pelvic fracture, urinary tract infection, vaginal infection, known neurologic disorders, respiratory diseases, menstruation at the time of assessment, history of spinal surgery, or history of PFM training (PFMT) during physiotherapy within the last two years. One hundred forty-two patients were excluded from the study. The remaining 140 patients who agreed to participate in the study were randomized to the PFMT group (n=70) or the control group (n=70) and were evaluated before and after the intervention. Randomization was carried out by the study coordinator using a computer-generated random number table by the prelabeled sealed envelope method. Based on random number table, patients were assigned to the two interventions. Data with regard to age, body mass index, waist/hip ratio, duration of urinary incontinence, number of pregnancies, and heaviest birth weight were collected from the medical records at the initial visit. All patients underwent a vaginal examination in the lithotomy position with an empty bladder. A preliminary assessment of PFM function was performed by an experienced pelvic floor physiotherapist using the palpation method2). The PERFECT, perineometric, and ultrasonographic measurements were performed three times, and the average of the three measurements was calculated. After these measurements, the stop test, pad test, and stress test were performed. A 30-minute rest period was given after each muscle strength test. The strength of the PFM was measured via palpation with one to two fingers, and PFM function was evaluated according to the PERFECT scheme, which includes assessments of power, endurance, number of repetitions, and number of fast (1 s) contractions. Additionally, every contraction was timed. Power was graded from 0 to 5, according to the Oxford grading system. The PERFECT scheme of PFM evaluation was recorded and used as an exercise program for the PFMT group2). A Peritron 9300V perineometer (Cardio Design, Victoria, Australia) was used to measure the strength of PFM contractions. A diagnostic ultrasound imaging unit set in B mode (Ultrasonix ES500, Ultrasonix Medical Corporation, Richmond, BC, Canada) with a 3.5-MHz curved array transducer was used for TAUS measurement. Two investigators with at least two years of experience in using TAUS examined all of the patients. A marker (X) was placed on the image of the central portion of the bladder base at the junction of the hyper- and hypoechoic structures. The patients were asked to perform three PFM contractions with a 10-s rest between each contraction, and each image was captured at the point of maximal displacement and again marked with an X. The displacement was measured as the distance between the two points marked with X (mm). A physiotherapist confirmed the correctness of PFM contraction by examining any undesirable movement or contraction of other muscles12). Only contractions with cephalic movement of the bladder base were accepted as correct. The stop test was performed by slowing or stopping urine flow after initiation of voiding with a full bladder. The one-hour pad test was performed by measuring the weight differences of pads after completion of recommended types of exercises. The stress test was performed by having the individual relax and then cough vigorously while the examiner observed them for urine loss from the urethra14). The patients in the PFMT group participated in a 12-week exercise program. PFM exercises were practiced two days per week for the first three weeks with intravaginal digital palpation in different positions and monitoring by a physiotherapist. The patients performed the exercise program at home for the remaining 9 weeks. The exercises were individualized according to the degree of pelvic floor weakness, loss of proprioception, and the patient’s tolerance. The exercise program included the positions in which the exercise would be done, the number of repetitions of slow and fast contractions, the duration of rest between the contractions, and the number of repetitions in a day and in a week. After isometric exercises, concentric and eccentric exercises were then respectively performed with a frequency of 2–7 sets per day with maximal voluntary contraction. The data analysis was performed using a statistical analysis software (SPSS, v15.0, SPSS Inc, Chicago, IL, USA). The
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variables were investigated with the Kolmogorov-Smirnov test to determine whether they were normally distributed. Descriptive analyses are presented using the means and standard deviations for normally distributed PERFECT, ultrasonography, perineometry, and demographic variables. The independent samples t-test and chi-square test were used for continuous and categorical variables, respectively, to test the difference between the pre- and posttreatment values in the study and control groups. The association among TAUS measurements, perineometry results, and three components of the PERFECT scheme (endurance, repetitions and fast) was assessed using Pearson’s coefficient of correlation, while Spearman’s rho was used to determine the association between TAUS measurement and digital palpation testing. A priori analysis for power indicated that 51 patients in each group were needed to produce 80% power for detecting a large-size effect (assuming a correlation ρ of 0.50 and population correlation ρ of 0.72) based on a one-tailed alpha value of 0.05. A post hoc statistical power analysis showed that with the effect size (r) of 0.47, this study has 85% power to detect a significant correlation between the TAUS measurements and perineometry with an overall 5% type-I error level. The G*Power 3 computer program was used for the power analysis15). An overall p-value of less than 0.05 was considered a statistically significant result.
RESULTS Among the 282 incontinent women, 91 were excluded from the study due to the exclusion criteria, and 51 did not agree to participate in the study. The remaining 140 patients were randomly divided into 2 groups. Each group initially had 70 patients, but 24 women did not complete the study, resulting in a drop-out rate of 17.14%. Five patients in the exercise group were excluded from the study because they did not participate in at least 75% of the treatment sessions. Nineteen patients in the control group who did not attend their secondary assessments due to personal reasons were also not included in the study (one woman had a change in her work situation, two women had other health problems, 16 women did not accept a second vaginal evaluation). Ultimately, the study was completed with 65 patients (27 with stress UI, 23 with urge UI, and 15 with mixed type UI) in the exercise group and 51 patients (21 with stress UI, 17 with urge UI, and 13 with mixed type UI) in the control group. Table 1 shows the baseline demographic and clinical characteristics of the patients. Comparison of the groups showed no significant differences at baseline for age, body mass index, waist/hip ratio, duration of UI symptoms, number of pregnancies, and heaviest birth weight. There were statistically significant differences between the stress test measurements before and after exercise in the treatment group (15.4% vs. 3.1% positive stress test respectively, p
